🏥 Medical Devices • 6,627 recalls
Siemens Healthcare Diagnostics
Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Philips Medical Systems
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.
Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either "Low gas sample flow" or "Check sample gas out".
Childrens Medical Ventures
The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.
Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.
Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.